The Effect of Acute and Chronic Exercise at the Metabolic Syndrome and Markers of Inflammation in Obese Subjects

NCT00700245 | Unknown

• 1 other identifier: 20060053
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The human adipose and muscle -tissue produce and release a number of bioactive proteins which contributes to the chronic low grade of inflammatory status which is associated with obesity and plays an important role in the pathogenesis of type 2 diabetes and cardiovascular diseases. Study 1: Our aim is to investigate if exercise has independent and additive effects in combination with diet-induced weight loss on circulating levels of inflammatory markers and mRNA levels in subcutaneous adipose tissue (SAT) and skeletal muscle tissue (SM. Study 2: Our aim is to investigate whether gender and weight status plays a role in the metabolic response during two hours of acute exercise

Conditions

Obesity; Healthy

Keywords

Obese; Adults

Outcome Measures

Primary Outcomes (2)

• Changes in inflammatory markers as Adiponectin, MCP-1, Interleukin-6 and CRP. Moreover changes in body composition quantified with MRI

  8 weeks and 12 weeks

• Change in Interleukin-6 and other inflammatory markers in plasma, adipose tissue and muscle tissue

  60, 120 240 minutes

Study Arms (3)

EXO

ACTIVE COMPARATOR

Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction),

Behavioral: Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction)

DIO

ACTIVE COMPARATOR

Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet)

Behavioral: Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet

DEX

ACTIVE COMPARATOR

Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).

Behavioral: Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).

Interventions

Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction) BEHAVIORAL

The exercise intervention for subjects in the EXO consisted of supervised aerobic exercise three times per week with a duration of 60 -75 minutes pr. training session, with an estimated energy expenditure of 500-600 kcal per session. The subjects could choose between different modes of exercise; stationary bicycling, jogging on a treadmill or stair stepping.

EXO

Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet BEHAVIORAL

Subjects in the DIO group were prescribed a liquid VLED(Nupo, Copenhagen) of respectively 600 and 800 kcal pr. day (proteins 41 g, carbohydrates 29 g, fat 5.6 g. pr 100 gram) for eight weeks followed by a weight maintenance diet for four weeks.

DIO

Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks). BEHAVIORAL

The exercise intervention for subjects in the DEX group consisted of supervised aerobic exercise three times per week with a duration of 60 -75 minutes pr. training session, with an estimated energy expenditure of 500-600 kcal per session

DEX

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 years,
• obese (30 kg/m2 \< BMI \< 40 kg/m2) physically inactive (\<30 minutes pr. day)
• and weight stabile for at least three months (± 2 kg of current body weight)

You may not qualify if:

• cardiovascular disease,
• type 2 diabetes, pregnancy or orthopaedic difficulties causing inability to undertake an exercise program

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Department of Medicine and Endocrinology C

Aarhus, Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tore SB Christiansen, Master of health science

CONTACT

004589497737; tore.christiansen@ki.au.dk

Søren K Paulsen, MD

CONTACT

004589497736; skpaulsen@ki.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 18, 2008
• Study Start: September 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: March 1, 2009
• Last Updated: June 18, 2008

Record last verified: 2008-06

Locations

DK (1)